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Propensity score matching analysis to evaluate the comparative effectiveness of daratumumab versus real-world standard of care therapies for patients with heavily pretreated and refractory multiple myeloma.

Abstract
Daratumumab is a CD38-directed monoclonal antibody approved for treating multiple myeloma (MM). Propensity score matching (PSM) based on individual patient data (IPD) was conducted to compare overall survival (OS) and progression-free survival (PFS) for daratumumab versus real-world standard of care (SOC). IPD for patients with relapsed and refractory (RR) MM treated with daratumumab monotherapy were from the GEN501 and SIRIUS studies; IPD for patients treated with SOC were from an International Myeloma Working Group (IMWG) chart review of patients with RRMM. Prior to PSM, patients treated with daratumumab had significantly longer OS (median 20.1 vs. 10.1 months, hazard ratio [HR] = 0.51 [0.39-0.67]) and PFS (median 4.0 vs. 2.8 months, HR = 0.73 [0.58-0.92]) than patients treated with SOC therapies. After PSM, daratumumab maintained a significantly prolonged OS (19.9 vs. 9.2 months, HR = 0.44 [0.31-0.63]) and PFS (3.9 vs. 1.6 months, HR = 0.56 [0.42-0.74]) compared with SOC.
AuthorsShaji Kumar, Brian Durie, Hareth Nahi, Ravi Vij, Meletios A Dimopoulos, Efstathios Kastritis, Evangelos Terpos, Xavier Leleu, Meral Beksac, Hartmut Goldschmidt, Jens Hillengass, Zhuo Su, Brian Hutton, Chris Cameron, Imran Khan, Annette Lam
JournalLeukemia & lymphoma (Leuk Lymphoma) Vol. 60 Issue 1 Pg. 163-171 (01 2019) ISSN: 1029-2403 [Electronic] United States
PMID29741423 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Monoclonal
  • daratumumab
Topics
  • Antibodies, Monoclonal (pharmacology, therapeutic use)
  • Antineoplastic Combined Chemotherapy Protocols (pharmacology, standards, therapeutic use)
  • Clinical Trials, Phase I as Topic
  • Clinical Trials, Phase II as Topic
  • Drug Resistance, Neoplasm
  • Humans
  • Male
  • Middle Aged
  • Multiple Myeloma (drug therapy, mortality)
  • Neoplasm Recurrence, Local (drug therapy, mortality)
  • Progression-Free Survival
  • Propensity Score
  • Standard of Care
  • Survival Analysis
  • Time Factors

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